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New treatment option for Pediatric ALL
Official title HIIT in Pediatric Heart Transplant Recipients (MedBIKE™)
ClinicalTrials.gov ID: NCT05451979
What this study is testing
- What it's testing
- Heart transplantation is the long-term treatment for children and adults with advanced heart failure. Post-transplant outcomes have improved over time, such that 50% of pediatric heart transplant recipients (HTR) remain alive with a need for re-transplantation 17-years following the initial transplant.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 18
You may be able to join if
- Pediatric heart transplant recipients, at least 6-months post heart transplantation
- Aged 10-18 years
You likely can't join if
- Non-English speaking (thus limiting communication during the MedBIKE™ sessions)
- Home environment cannot accommodate the MedBIKE™ system (for example, space limitations)
- History of multiorgan transplant
- Adult unavailable to supervise the home-based exercise sessions
- Episode of clinical antibody- or cellular-mediated rejection within 3-months of the baseline assessment
- Previous involvement in a cardiac rehabilitation or exercise intervention program
See the full eligibility criteria
- Pediatric heart transplant recipients, at least 6-months post heart transplantation
- Aged 10-18 years
- Non-English speaking (thus limiting communication during the MedBIKE™ sessions)
- Home environment cannot accommodate the MedBIKE™ system (for example, space limitations)
- History of multiorgan transplant
- Adult unavailable to supervise the home-based exercise sessions
- Episode of clinical antibody- or cellular-mediated rejection within 3-months of the baseline assessment
- Previous involvement in a cardiac rehabilitation or exercise intervention program
- Primary cardiologist has exercise restricted the participant or counsels against participation
- Previous exercise stress test demonstrating sustained arrhythmias, ST segment elevation or depression greater than 3mm, an inappropriate rise in blood pressure (BP) (\ 200 mmHg, or symptoms of chest pain or syncope
- Resting arterial saturation \<85% or oxygen requirements
- Moderate ventricular systolic dysfunction (or worse) at the most recent echocardiogram
- History of chest pain on exertion
- Unrepaired/unpalliated CHD
- Arrhythmias in the last year (including supraventricular tachycardia, ventricular tachycardia, atrioventricular block (Mobitz II or worse))
- New York Heart Association class II or worse symptoms
- Active medical inter-current illness limiting ability to participate
- Cognitive impairment limiting the communication needed for the HIIT program
- Extracardiac or congenital abnormality limiting the participant's functional ability to exercise
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.